High Intensity Interval Gait Training in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

The Effects of High Intensity Interval Gait Training vs. Moderate Intensity Continuous Gait Training in Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05560880
• Other study ID #: 2022-0261
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Hunter College of City University of New York
• Contact: Herb Karpatkin, DSc
• Phone: 212-396-7115
• Email: hkarpatk[@]hunter.cuny.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Over 90% of persons with MS (pwMS) complain of difficulty with walking. High intensity interval gait training (HIIGT), where persons alternate brief periods of walking at high speeds with periods of rest has been found to improve walking in other neurologic diagnoses. However its impact on pwMS is not known. Most gait training in MS is done continuously at a slower pace. The purpose of this study is to compare the effects of HIIGT to traditional Moderate Intensity Continuous Gait Training (MICGT) in pwMS.

Description:

Purpose: To determine whether pwMS will have greater improvements in gait with HIIGT as compared to MICGT.

Primary Question: Does HIIGT results in greater improvements in gait parameters in pwMS than MICGT? Secondary question: Will HIIGT result in greater improvements in balance, lower extremity strength, lower extremity range of motion and HR when compared to MICGT in pwMS?

Hypothesis: HIIGT will result in greater improvements in gait parameters in pwMS than MICGT.

Justification: Previous research has shown that MICGT, moderate intensity interval training and high intensity non-gait interval training is effective in pwMS. HIIGT has been shown to be effective in persons with stroke but the effects of HIIGT on pwMS are not known.

Outcomes and dissemination of information: We will present our findings at national conferences and submit manuscripts of our findings to the appropriate peer reviewed journal.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Persons diagnosed with Multiple Sclerosis.

• The ability to walk for 6 minutes continuously with or without assistive device.

• The ability to read, understand and sign a consent form so that they are able to understand the study we are doing

• Above the age of 18

Exclusion Criteria:

• Any cardiopulmonary, orthopedic, or non-MS neurologic disease as we are only examining the effects of MS and need to rule out the impact of other conditions

• Report of a recent exacerbation. Rationale: the impact of the rationale can interfere with the impact of the independent variables

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• High Intensity Interval Gait training
Subjects will walk as fast as they can for 30 seconds, followed by a 60 second seated recovery. They will be guarded by a physical therapist at all times.
• Moderate Intensity Interval gait training
subjects will walk for 20 minutes at theri best comfortable pace

Locations

Country	Name	City	State
United States	Hunter College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hunter College of City University of New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Six minute walk test time from before to after the intervention	Subjects will walk for six minutes at their best comfortable pace. They will be guarded by physical therapist for the entire walk. Total distance, distance per minute, and heart rate will be measured.	The test will be administered to all subjects one week before and one week after the intervention.The test will be administered to all subjects one week before and one week after the intervention.
Secondary	Change in Functional gait assessment score from before to after the intervention	Used to assess balance during different walking conditions	Will be done in the week before and the week after the intervention.Will be done in the week before and the week after the intervention.
Secondary	Change in Hand held dynamometry values from before to after the intervention	Use of the strain gauge to determine lower extremity muscle strength	Will be done the week before and the week after the intervention.
Secondary	Change in Multiple sclerosis impact scale 29 from before to afterthe intervention	Quality of life measure where are the subject subjectively rates the impact of multiple sclerosis on their life	Performed in the week before and the week after the intervention.